Brief Job Description
The Process Engineer II owns the technical process for assigned IDAP equipment, working with limited supervision to keep assigned processes capable, compliant, and improving. Drives continuous improvement, validation, and troubleshooting on assigned equipment, and authors the controlled documentation that supports it. Partners with Manufacturing, Quality, Maintenance, and equipment suppliers to resolve technical issues and deliver assigned projects on time.
Job Responsibilities
Process & Equipment Improvement
- Owns the technical process for assigned IDAP equipment; defines and maintains centerlines, critical process parameters, material fit for use, and operating procedures to ensure a capable, repeatable process.
- Drives continuous improvement for assigned IDAP processes, including changeover reduction, yield and OEE improvements, maintenance reliability, and waste reduction.
- Tracks equipment data, capabilities, utilization, efficiencies, and obsolescence for assigned assets; manages asset lifecycle and develops user requirements for new asset procurement.
- Provides engineering and project management for assigned projects, including developing project justification, tracking milestones, and informing capital planning.
Validation & Technical Support
- Leads validation activities for assigned processes, defining success criteria, confirming process capability, and maintaining validated state through change.
- Authors and reviews URS, FAT, SAT, commissioning, and IQ/OQ/PQ protocols and reports for assigned processes.
- Troubleshoots assigned IDAP processes, diagnosing and resolving equipment and process deviations, including on-call support as required.
- Works directly with equipment and material suppliers on assigned processes to resolve technical issues.
Quality Systems & Compliance
- Identifies, develops, and manages implementation of change controls for assigned processes to improve performance and address root causes.
- Performs and maintains risk management activities for assigned new and existing processes and equipment.
- Initiates deviations and independently leads technical investigations and impact assessments for assigned processes.
- Authors and reviews controlled documents including SOPs, Batch Records, and Rework procedures for assigned processes.
- Supports regulatory inspections as the process owner for assigned IDAP equipment.
Training & Development
- Identifies technical training requirements for Operations, Engineering, and Maintenance for assigned processes, and develops and delivers training materials.
Minimum Qualifications
- Prior experience or exposure in a GMP or regulated manufacturing environment, with a demonstrated ability to follow controlled procedures and quality standards.
- Prior training or hands-on experience in one or more IDAP-relevant technologies, such as mechanics, hydraulics, pneumatics, vacuum systems, electronics, PLCs, HMI, computerized systems, vision systems, aseptic/controlled environments, packaging equipment, process or cleaning validation, or change control.
- Baseline proficiency in at least one of the following disciplines: automation/controls, aseptic/packaging equipment, process/materials, maintenance, or validation.
- Ability to work with limited supervision, exercising independent judgment on assigned processes.
Preferred Qualifications
- Bachelor's degree in Engineering or related science, and 2+ years of experience in a GMP or regulated pharmaceutical manufacturing environment.
- Experience with project management and process-improvement methodologies (Six Sigma, Lean).
- Expertise in at least one of the following disciplines: automation/controls, aseptic/packaging equipment, process/materials, maintenance, or validation.
Physical & Work Environment
Work may involve extended hours, including evenings and weekends, depending on project deadlines and operational needs, as well as occasional travel.
Physical demands may include prolonged sitting with occasional standing, walking, bending, stooping, twisting, and reaching; the ability to lift or carry up to 20 lbs; infrequent work at heights up to 5 ft; occasional exposure to noise, chemicals, and moving machinery; and the use of personal protective equipment. The role also requires specific visual acuity (including extended computer use, color vision, and depth perception) and the ability to hear and distinguish sounds consistent with interpersonal and group conversation.
The items described here are representative of those that must be met successfully to perform the essential functions of this job.
The work schedule listed reflects the employee's expected schedule at the time of hire. The Company reserves the right to modify work schedules at any time, including a request to work overtime, with or without notice, based on business needs, operational requirements, or other considerations. Nothing in this description creates a guarantee of specific hours, days, or shift assignments.
Sponsorship or support for work authorization, including visas, is not available for this position.
